MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYMPHION; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA

Model Number	FG-0612-R
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on november 4, 2019 that a symphion controller was used in a dilation and curettage (d and c) procedure performed on (b)(6) 2019.According to the complainant, when they plugged in the resecting device into the controller the device started resecting and reciprocating on its own.The procedure was aborted due to this event.There were no patient safety issues reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation on november 4, 2019 that a symphion controller was used in a dilation and curettage (d and c) procedure performed on (b)(6), 2019.According to the complainant, when they plugged in the resecting device into the controller the device started resecting and reciprocating on its own.The procedure was aborted due to this event.There were no patient safety issues reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code 1198 captures the reportable event of electrical/electronic property problem.Block h10:investigation result a symphion controller was returned for evaluation.Based on a thorough review of the complaint, they found an intermittent operation with the returned footswitch.The footswitch cable was pullin out of the male plug connector, also found corrosion on the motor pcba inside the console.The reported complaint of electrical issue was confirmed.The fault was most likely caused by unintended mishandling of the footswitch connector causing physical damage to the connector.Therefore, the most probable cause for this complaint is unintended use error caused or contributed to event which indicates that the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.A review of the device history record (dhr) confirmed that the device met all material, assembly and product specifications.

• Brand Name: SYMPHION
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9341891
• Report Number: 3005099803-2019-05664
• Device Sequence Number: 16606891
• Product Code: PGT
• UDI-Device Identifier: 08714729897279
• UDI-Public: 08714729897279
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG-0612-R
• Device Catalogue Number: 74076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1